Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all, 
Once you get the FDA clearance/approval, etc., can you assume that you cover also US states regs and you can distribute your product all over US?
If not, what is the best approach to handle the different states regulations for electromedical devices. Is there a good reference where I can find all that are mandatory and apply to medical devices?
I found a NIST guide (https://nvlpubs.nist.gov/nistpubs/ir/2016/NIST.IR.8118.pdf) that cite some but I am not sure it is comprehensive and it seems quite old (2016).

What about other federal regs? I am aware we should address FCC for wireless/bluetooth, OSHA for NRTL certification, FTC for promotions. Anything else I am missing (e.g., waste, chemicals, etc.)? 
Please let me know your thoughts. Thanks

Hello Anon,

My experience in this has been waning as not been directly involved, but unfortunately there can be differences in requirements between States within the United States.  Generally most of them are the same, though there are States like California or New York which sometimes have stricter or additional requirements for electrical devices, fire prevention, etc.  Including there may also be specific requirements by hospitals or bioengineering groups within hospitals or groups of hospitals which needs to be accounted for when placing products in different places in the US.  I am not aware of a central database or listing somewhere for the different products and requirements.  In my experience, once our device was cleared for marketing or registered, we would start selling in the any and all of the States, but when an additional requirement arose (had many from California, Texas, Florida, New York, New Jersey) just dealt with the issue at the moment.  Then we kept a database of "deviations" from different States for our products, and ensured these became part of our design inputs and regulatory/safety requirements.  And yes it crossed many different areas such as electrical safety, fire safety, OSHA, wireless, disposal - kept me busy !

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 03-Sep-2020 06:19
From: Anonymous Member
Subject: Medical Devices - US States regulations

This message was posted by a user wishing to remain anonymous

Hi all,
Once you get the FDA clearance/approval, etc., can you assume that you cover also US states regs and you can distribute your product all over US?
If not, what is the best approach to handle the different states regulations for electromedical devices. Is there a good reference where I can find all that are mandatory and apply to medical devices?
I found a NIST guide (https://nvlpubs.nist.gov/nistpubs/ir/2016/NIST.IR.8118.pdf) that cite some but I am not sure it is comprehensive and it seems quite old (2016).

What about other federal regs? I am aware we should address FCC for wireless/bluetooth, OSHA for NRTL certification, FTC for promotions. Anything else I am missing (e.g., waste, chemicals, etc.)?
Please let me know your thoughts. Thanks

Also, if your device is used for Emergency Medicine and is used in helicopters it must meet Federal Aviation Administration regulations.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Original Message:
Sent: 04-Sep-2020 05:17
From: Richard Vincins
Subject: Medical Devices - US States regulations

Hello Anon,

My experience in this has been waning as not been directly involved, but unfortunately there can be differences in requirements between States within the United States.  Generally most of them are the same, though there are States like California or New York which sometimes have stricter or additional requirements for electrical devices, fire prevention, etc.  Including there may also be specific requirements by hospitals or bioengineering groups within hospitals or groups of hospitals which needs to be accounted for when placing products in different places in the US.  I am not aware of a central database or listing somewhere for the different products and requirements.  In my experience, once our device was cleared for marketing or registered, we would start selling in the any and all of the States, but when an additional requirement arose (had many from California, Texas, Florida, New York, New Jersey) just dealt with the issue at the moment.  Then we kept a database of "deviations" from different States for our products, and ensured these became part of our design inputs and regulatory/safety requirements.  And yes it crossed many different areas such as electrical safety, fire safety, OSHA, wireless, disposal - kept me busy !

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 03-Sep-2020 06:19
From: Anonymous Member
Subject: Medical Devices - US States regulations

This message was posted by a user wishing to remain anonymous

Hi all,
Once you get the FDA clearance/approval, etc., can you assume that you cover also US states regs and you can distribute your product all over US?
If not, what is the best approach to handle the different states regulations for electromedical devices. Is there a good reference where I can find all that are mandatory and apply to medical devices?
I found a NIST guide (https://nvlpubs.nist.gov/nistpubs/ir/2016/NIST.IR.8118.pdf) that cite some but I am not sure it is comprehensive and it seems quite old (2016).

What about other federal regs? I am aware we should address FCC for wireless/bluetooth, OSHA for NRTL certification, FTC for promotions. Anything else I am missing (e.g., waste, chemicals, etc.)?
Please let me know your thoughts. Thanks

As far as I know there are many Special laws in different states, for example CP65 in California. So to get 100% I think one would Need to scan all the state laws...            ​

------------------------------
Immanuel Campen
Manager, Regulatory Affairs
Lübeck
Germany
------------------------------

Original Message:
Sent: 03-Sep-2020 06:19
From: Anonymous Member
Subject: Medical Devices - US States regulations

This message was posted by a user wishing to remain anonymous

Hi all,
Once you get the FDA clearance/approval, etc., can you assume that you cover also US states regs and you can distribute your product all over US?
If not, what is the best approach to handle the different states regulations for electromedical devices. Is there a good reference where I can find all that are mandatory and apply to medical devices?
I found a NIST guide (https://nvlpubs.nist.gov/nistpubs/ir/2016/NIST.IR.8118.pdf) that cite some but I am not sure it is comprehensive and it seems quite old (2016).

What about other federal regs? I am aware we should address FCC for wireless/bluetooth, OSHA for NRTL certification, FTC for promotions. Anything else I am missing (e.g., waste, chemicals, etc.)?
Please let me know your thoughts. Thanks

Also have a look at 21 CFR 808 : EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS. With kindest regards, 

------------------------------
Ary Saaman
Director, Regulatory Affairs
Lausanne
Switzerland
------------------------------

Original Message:
Sent: 03-Sep-2020 06:19
From: Anonymous Member
Subject: Medical Devices - US States regulations

This message was posted by a user wishing to remain anonymous

Hi all,
Once you get the FDA clearance/approval, etc., can you assume that you cover also US states regs and you can distribute your product all over US?
If not, what is the best approach to handle the different states regulations for electromedical devices. Is there a good reference where I can find all that are mandatory and apply to medical devices?
I found a NIST guide (https://nvlpubs.nist.gov/nistpubs/ir/2016/NIST.IR.8118.pdf) that cite some but I am not sure it is comprehensive and it seems quite old (2016).

What about other federal regs? I am aware we should address FCC for wireless/bluetooth, OSHA for NRTL certification, FTC for promotions. Anything else I am missing (e.g., waste, chemicals, etc.)?
Please let me know your thoughts. Thanks

It depends on the type of device. For instance, for things like X-rays and lasers, individual states often have additional requirements - not so much for "approval" but licensing for placement of devices in the state. These often have a fee and some reporting requirements like an annual listing of devices in the state (and their locations) etc. Some state may have other types of requirements as well, such as California's earthquake proofing requirements for many types of electronic medical devices. You should verify before shipping into a specific state.

For many types of devices FDA clearance/approval is all you need, but that is not always the case. Note also that if the device is radiation emitting, 21CFR1000 and its related sections may apply.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 03-Sep-2020 06:19
From: Anonymous Member
Subject: Medical Devices - US States regulations

This message was posted by a user wishing to remain anonymous

Hi all,
Once you get the FDA clearance/approval, etc., can you assume that you cover also US states regs and you can distribute your product all over US?
If not, what is the best approach to handle the different states regulations for electromedical devices. Is there a good reference where I can find all that are mandatory and apply to medical devices?
I found a NIST guide (https://nvlpubs.nist.gov/nistpubs/ir/2016/NIST.IR.8118.pdf) that cite some but I am not sure it is comprehensive and it seems quite old (2016).

What about other federal regs? I am aware we should address FCC for wireless/bluetooth, OSHA for NRTL certification, FTC for promotions. Anything else I am missing (e.g., waste, chemicals, etc.)?
Please let me know your thoughts. Thanks